Infant nutrition delivering metabolic benefits

ABSTRACT

The present invention relates to a complementary nutritional composition characterized by a low glycemic load and/or index and/or comprising an ingredient characterized by a low glycemic index for use in treatment, prevention and/or reducing the risk of a metabolic syndrome disorder appearing later in life.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 16/092,277, filed on Oct. 9, 2018, which is a National Stage ofInternational Application No. PCT/EP2017/058481, filed on Apr. 10, 2017,which claims priority to European Patent Application No. 16164763.1,filed on Apr. 11, 2016, European Patent Application No. 16166722.5,filed on Apr. 22, 2016, and European Patent Application No. 16167945.1,filed on May 2, 2016, the entire contents of which are beingincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a nutritional composition for thecomplementary feeding period for use in treatment, prevention and/orreducing the risk of a metabolic syndrome disorder appearing later inlife.

BACKGROUND

Data from observational studies suggest that postprandial glycaemia isimplicated in development of obesity and chronic metabolic disease suchas type 2-diabetes and cardiovascular disease in adults.

High/prolonged insulin response is also known to be linked to insulinresistance and risk of type 2 diabetes in adults.

Although extensive data is available on the glycemic index (GI) ofdifferent foods and the potential health impact for adults, especiallydiabetics, much less is known for infant/children, especially healthy.

The prenatal and early postnatal periods are currently recognized ascritical windows for early programming. It is now recognized thatsuboptimal nutrition during critical periods of development may inducelong-term alterations in organ structures or functions, which canpredispose humans to later chronic diseases.

In particular, evidence exists that prenatal and early postnatalnutrition (lactation) plays a role in determining susceptibility todevelop one or more metabolic syndrome disorders later in life (see forexample Srinivasan M. et al, “A high carbohydrate diet in the immediatepostnatal life of rats induces adaptations predisposing to adult-onsetobesity” Journal of endocrinology (2008), 197, 565-574). Anyway, verylittle is known in relation to the long term metabolic effect of foodsintended for complementary feeding period and later feeding of youngchildren (<3 years of age).

Hence, a nutritional composition for administration during thecomplementary feeding period, which reduces the risk for development ofmetabolic syndrome disorders later in life would be advantageous.

There is a particular need for specific nutritional compositions thatmay be administered at particular intervention windows during the earlylife of the young children and which may be capable to reduce the risk,prevent, or reduce the severity of sub-optimal health conditions usuallyassociated with metabolic syndromes, such as over-weight, obesity,diabetes or even cardiovascular diseases.

There is an even particular need in these infants at higher risk todevelop such sub-optimal conditions, for example because of theirgenetic heritage, of the health conditions of their parents, of theirdifficult early development.

There is also a need for nutritional compositions to be administered atparticular intervention windows during the early life of the youngchildren wherein macronutrients present in the composition would beoptimized towards latest nutritional recommendations.

Hence in one embodiment, a nutritional composition for administrationduring the complementary feeding period which is nutritionally balancedand which reduces the risk for development of metabolic syndromedisorders later in life would be advantageous.

SUMMARY

The present inventors have surprisingly shown that rats which were fedduring the complementary feeding period with a diet characterized by alow glycemic index and low glycemic load experienced a protective effectagainst the impairment of glucose homeostasis and insulin response, evenwhen exposed to an adipogenic diet as adult rats. In contrast, ratswhich had been fed during the complementary feeding period a diet withhigher glycemic index and glycemic load as pups were not protected.

Accordingly, a first aspect of the present invention relates to acomplementary nutritional composition characterized by a low glycemicload and/or index for use in treatment, prevention and/or reducing therisk of a metabolic syndrome disorder appearing later in life.

The invention also provides a method of treating, preventing, and/orreducing the risk that an infant or young child will develop a metabolicsyndrome disorder later in life; in particular when challenged withadipogenic diet, said method comprising the step of administering at anage of the infant or young children comprised between 4 months and 5year, a nutritional composition characterized by a low glycaemic loadand/or index.

In another aspect, the present invention provides a complementarynutritional composition comprising at least one ingredient having lowglycemic index for use in treatment, prevention and/or reducing the riskof a metabolic syndrome disorder appearing later in life.

In another aspect, the present invention provides a complementarynutritional composition comprising at least one carbohydrate-basedingredient having low glycemic index for use in treatment, preventionand/or reducing the risk of a metabolic syndrome disorder appearinglater in life.

Another aspect of the present invention relates to the use of at leastone carbohydrate-based ingredient having low glycemic index for thepreparation of a complementary nutritional composition for use intreatment, prevention or reducing the risk of a metabolic syndromedisorder later in life in an individual.

In a further aspect, the present invention provides for the use of acomplementary nutritional composition as described herein for treating,preventing and/or reducing the risk of a metabolic syndrome disorderappearing later in life.

The invention also provides a method of treating, preventing, and/orreducing the risk that an infant or young child will develop a metabolicsyndrome disorder later in life; in particular when challenged withadipogenic diet, said method comprising the step of administering at anage of the infant or young children comprised between 4 months and 5year, a nutritional composition comprising at least ingredient, forexample at least one carbohydrate based ingredient, having low glycaemicload and/or index.

In a further aspect, the present invention provides a complementarynutritional set which comprises a complementary nutritional compositioncharacterized by a low glycaemic load and/or index and/or comprising aningredient with low glycaemic index for use in treatment, preventionand/or reducing the risk of a metabolic syndrome disorder appearinglater in life.

In another aspect, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   legume in amount ranging from 0 to 40%, for example from 1 to        40%, for example, from 5 to 40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In another aspect, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        from 30 to 55% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fats in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   milk-based ingredient in an amount ranging from 0 to 30% w/w,        for example from 1 to 25% w/w, for example from 5 to 25% w/w;    -   legume in amount ranging from 0 to 40%, for example from 1 to        40% w/w, for example from 5 to 40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In another aspect, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        30 to 55% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   milk-based ingredient in an amount ranging from 0 to 30% w/w,        for example from 1 to 25% w/w, for example from 5 to 25% w/w;    -   legume in amount ranging from 0 to 40%, for example from 1 to        40% w/w, for example from 5 to 40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w;

for use in treatment, prevention and/or reducing the risk of a metabolicsyndrome disorder appearing later in life.

In another aspect, the present invention provides a method of treating,preventing, and/or reducing the risk that an infant or young child willdevelop a metabolic syndrome disorder later in life; in particular whenchallenged with adipogenic diet, said method comprising the step ofadministering at an age of the infant or young children comprisedbetween 4 months and 5 year, a nutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        30 to 55% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   milk-based ingredient in an amount ranging from 0 to 30% w/w,        for example from 1 to 25% w/w, for example from 5 to 25% w/w;    -   legume in amount ranging from 0 to 40%, for example from 1 to        40% w/w, for example from 5 to 40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In a further aspect, the present invention provides a complementarynutritional set which comprises a complementary nutritional compositioncomprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        from 30 to 55% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   milk-based ingredient in an amount ranging from 0 to 30% w/w,        for example from 1 to 25% w/w, for example from 5 to 25% w/w;    -   legume in amount ranging from 0 to 40%, for example from 1 to        40%, for example from 5 to 40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 shows a diagram of the experimental design of the study describedin Example 1.

FIG. 2 shows diagram of body weight observed for the different groups ofExample 1 from day 0 to day 21.

FIG. 3 shows diagrams of energy intake for the three groups of Example 1during intervention complementary feeding period (Phase I) and follow-upperiod (Phase II).

FIG. 4 shows diagrams of baseline blood glucose levels after 8 hours offood deprivation for the three groups in the experiment describedExample 1.

FIG. 5 shows diagrams of baseline blood insulin levels after 8 hours offood deprivation for the three groups in the experiment described inExample 1.

FIG. 6 shows postprandial increase in glucose in response to theproducts tested in Example 9.

FIG. 7 shows the postprandial increase in insulin in response to theproducts tested in Example 9.

FIG. 8 shows glucose incremental area under the curve (IAUC) ofprototypes 1 and 2 of Example 7 relative to glucose IAUC of Referenceproduct from the same example.

FIG. 9 shows insulin IAUC of prototypes 1 and 2 of Example 9 relative toinsulin IAUC of Reference product from the same example. Detaileddescription of the invention

DEFINITIONS

Prior to discussing the present invention in further details, thefollowing terms and conventions will first be defined:

In the context of the present invention, mentioned percentages areweight/weight percentages unless otherwise stated.

The term “and/or” used in the context of the “X and/or Y” should beinterpreted as “X”, or “Y”, or “X and Y”.

Numerical ranges as used herein are intended to include every number andsubset of numbers contained within that range, whether specificallydisclosed or not. Further, these numerical ranges should be construed asproviding support for a claim directed to any number or subset ofnumbers in that range. For example, a disclosure of from 1 to 10 shouldbe construed as supporting a range of from 1 to 8, from 3 to 7, from 4to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

All references to singular characteristics or limitations of the presentinvention shall include the corresponding plural characteristic orlimitation, and vice versa, unless otherwise specified or clearlyimplied to the contrary by the context in which the reference is made.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art.

The term “infant” means a child under the age of 12 months.

The term “young child” means a child older than 12 months and up until 5years of age (including toddlers).

The expression “child” generally indicates a human up to the age ofeighteen.

A “preterm” or “premature” means an infant or young child that was notborn at term. Generally it refers to an infant born prior to thecompletion of 37 weeks of gestation.

The expression “Term born infant” indicates an infant born after 37weeks gestation.

Within the context of the present invention, the term “Low birth weight”indicates a newborn's body weight below 2500 g (5.5 pounds), either as aresult of preterm birth (i.e. before 37 weeks of gestation) and/or dueto restricted foetal growth.

Within the context of the present invention, the term“Small-for-gestational-age (SGA)” refers to babies with birth weightsbelow the 10th percentile for babies of the same gestational age.

The expression “Postnatal period” is the period beginning immediatelyafter the birth of a child and extending for about six weeks.

The expression “nutritional composition” means a composition whichnourishes a subject. This nutritional composition is usually to be takenenterally, orally, parenterally or intravenously, and it usuallyincludes one of more nutrients selected from: a lipid or fat source, aprotein source. and a carbohydrate source. Preferably, a nutritionalcomposition is for oral use.

The expression “synthetic composition” means a mixture obtained bychemical and/or biological means, which can be chemically identical tothe mixture naturally occurring in mammalian milks. In one embodiment ofthe present invention, the complementary nutritional composition is asynthetic composition.

The expression “infant formula” means a foodstuff intended forparticular nutritional use by infants during the first four to sixmonths of life and satisfying by itself the nutritional requirements ofthis category of person (Article 1.2 of the European CommissionDirective 91/321/EEC of May 14, 1991 on infant formulae and follow-onformulae).

The expression “follow-on formula” means a foodstuff intended forparticular nutritional use by infants aged over four months andconstituting the principal liquid element in the progressivelydiversified diet of this category of person.

Within the context of the present invention, the term “Growing up milk(GUM)” indicates nutritional formula which may be given to children fromage of 12 months, in some instances after stopping the infant formula.The “growing-up milks” (or GUMs) are given from one year onwards. It isgenerally a milk-based beverage adapted for the specific nutritionalneeds of young children.

In the present context the term “infant cereal product” relates to acereal product that has been designed specifically for infants in orderto provide the required nutritional contribution to the infant.

The expression “baby food” means a foodstuff intended for particularnutritional use by infants during the first years of life.

The expression “fortifier” refers to liquid or solid nutritionalcompositions suitable for mixing with breast milk or infant formula.

The “mother's milk” should be understood as the breast milk or colostrumof the mother (=Human Breast Milk=HBM).

The term “complementary feeding period” indicates the process ofgradually introducing a mammal infant to what will be its adult diet andcomplementing the supply of its mother's milk with solid foods. Forhumans, the complementary feeding period typically starts at age between4 and 6 months of infant's age and is considered completed once theinfant is not anymore fed with any breast milk (or substitute infantformula), typically at 24 months. In one embodiment, the complementaryfeeding period is comprised between 4, for example 6, months and 24, forexample 18 months of infant's age.

The expression “complementary nutritional composition” or “a nutritionalcomposition for complementary feeding period” means a nutritionalcomposition as above defined which is designed to be administered to aninfant or young child at the time the complementary feeding periodstarts or afterwards. In one embodiment, the complementary nutritionalcomposition is administered during the complementary feeding period.This nutritional composition is usually to be taken enterally, orally,parenterally or intravenously, and it usually includes a lipid or fatsource, a protein source and a carbohydrate source. Optionally, thisnutritional compositions also comprise vitamins and minerals.Preferably, a nutritional composition is for oral use. Non-limitingexamples of complementary nutritional compositions are: infant cerealproducts, follow-on formula, GUMS, baby food. Infant cereal products maybe grouped in two main categories: complete cereal product which need tobe reconstituted in water as they already contain all the necessarynutrients to be delivered with the meal; and standard cereal productwhich are meant to be reconstituted with milk, infant formula, follow-onformula and/or GUMs.

The term “reducing the risk of” means that the event is less likely tohappen compared to the appropriate and usual reference (such as ageneral population or normal weight infants or young children).

The term “prevention” means that the event or disorder is prevented fromtaking place either completely, or partially (i.e., a milder form occursand/or occurs later). The terms prevention also comprises a reduction inthe severity of the event or disorder (or health condition) or areduction in the frequency of occurrence of such events or disorders ora delaying effect on such events or disorders.

The terms “normal weight/overweight/underweight” refer to theinternationally recognized tables for weight of infants, young childrenand children, and is in particular function of the age of the subject.

The expression “Glycemic index” or “Glycaemic index” (GI) in the contextof the present invention indicates a number associated with a particulartype of food/composition and/or ingredient that indicates the food'seffect on a person's blood glucose level. A value of 100 represents thestandard, an equivalent amount of pure glucose. The GI represents thetotal rise in a person's blood sugar level following consumption of thefood/composition/ingredient. The glycemic index of a food is defined asthe incremental area under the two-hour blood glucose response curve(AUC) following a 12-hour fast and ingestion of a food with a certainquantity of available carbohydrate (usually 50 g). The incremental AUCof the test food is divided by the incremental AUC of the standard(either glucose or white bread, giving two different definitions) andmultiplied by 100. The average GI value is calculated from datacollected in 10 human subjects. Both the standard and test food mustcontain an equal amount of available carbohydrate. The result gives arelative ranking for each tested food. The current validated methods useglucose as the reference food, giving it a glycemic index value of 100by definition.

The glycemic index of an ingredient or food composition may be measuredaccording to the method described in ISO (International Organization forStandardization) 26642:2010 (en).

Tables are available in the literature that list many types of foods andtheir GIs (see for example: “International table of glycemic index andglycemic load values: 2002”, Foster-Powell et al., The American Journalof Clinical Nutrition, 2002, 76: 5-56)

In one embodiment, when reference to GI is made in the context of thepresent invention, it is intended the GI for that particular ingredientor food which has been measured in healthy adults subjects.

Within the context of the present invention, the term “glycemic load” or“glycaemic load” (GL) of food is a number that estimates how much aserving of a food composition will raise a person's blood glucose aftereating it. Glycemic load accounts for how much carbohydrate is in aserving of food and how much each gram of carbohydrate in the serving offood raises blood glucose levels. Glycemic load is based on the glycemicindex (GI) of ingredients in the food composition, and is calculated bymultiplying the grams of available carbohydrate in the food times theavailable carbohydrate GI and then dividing by 100.

Glycemic Load in a serving of food with different type and amount ofavailable carbohydrate (CHO) is calculated as the sum of (GI ofavailable CHO A per serving×weight of CHO A in food)+(GI of availableCHO B×weight of CHO B per serving in food)+the same for each ofavailable CHO in food/100.

The appropriate serving size would be apparent to the person skilled inthe art for each type of food.

By way of guidance, exemplary serving size of use in the calculation ofGL for infants are below provided:

Complete infant cereal (to be reconstituted in water in 150 mL)=50 g

Standard infant cereal (to be reconstituted in 160 mL of infantformula)=25 g

Infant Formula=100 mL

Baby food=100 g.

Within the context of the present invention, the term “glucose response”(GR) indicates the post prandial blood glucose response (change in bloodconcentration) elicited when one serving of food is ingested and it ismeasured upon consumption of a serving of food regardless of the amountof available carbohydrate.

The glucose response may be measured as below described:

-   -   Glucose concentration in blood samples (capillary) is analysed        using calibrated YSI 2300 Stat Plus Glucose and Lactate        analyser.    -   The increase in the blood glucose concentration at different        time point (15 to 120 minutes after intake of test meals) is        calculated by reduction of the base-line value (blood glucose        before intake of test meals) from each values.    -   The total increase under two-hour blood glucose response curve        (IAUC) is calculated using the trapezoidal rule.    -   The results may be expressed as the % of response relative to        one reference product.

Within the context of the present invention, the term “Insulin index”(II) indicates a number associated with a particular type offood/composition and/or ingredient that indicates the food's effect on aperson's blood insulin level. The index is similar to the Glycemic Index(GI), but rather than relying on blood glucose, the II is based uponblood insulin levels.

The II may calculated based on 2 hours increase in plasma insulinconcentration upon a consumption of a test food compared to anisoenergetic food (1000 kJ bread) or upon consumption of a test foodwith 50 g available carbohydrate (compared to 50 g glucose).

The insulin index of an ingredient or food composition may be measuredaccording to the method described in the paper “An insulin index offood: the insulin demand generated by 100 kJ portions of common foods”,Holt HA S. et al, The American Journal of Clinical Nutrition, 1997; 66;1264-76)

Within the context of the present invention, the term “insulin response”(IR) indicates the 2 hours post prandial blood insulin response (changein concentration) elicited with quantity of tested food or meal ingestedand it is measured as the plasma insulin curve upon consumption of atest food compared to an adequate reference.

The insulin response may be measured as below described:

-   -   The concentration of plasma insulin concentration is measured by        Human Insulin Immunoassay Kit.    -   The increase in the plasma insulin concentration at different        time points was calculated as is explain above for glucose        (under GR);    -   The % response relative to reference product may be calculated        as explained above for glucose.

The expression “nutritional composition characterized by low Glycaemicindex” in the context of the present invention indicates a nutritionalcomposition having a glycemic index equal or lower than 70. For example,the glycemic index of such nutritional composition may be in oneembodiment lower or equal to 65, lower or equal to 60, lower or equal to55, lower or equal to 50. The expression has to be intended as opposedto “nutritional composition characterized by high Glycaemic index” whichindicates a nutritional composition having a glycemic index higher than70.

The expression “ingredient with low glycemic index” in the context ofthe present invention indicates a food ingredient having a glycemicindex equal or lower than 70. For example, the glycemic index of suchcarbohydrate-based ingredient may be in one embodiment lower or equal to65, lower or equal to 60, lower or equal to 55, lower or equal to 50,lower or equal to 45.

In the context of the present invention, the expression “nutritionalcomposition characterized by low Glycaemic load” or “low glycaemic loadnutritional composition” indicates a nutritional composition having aglycemic load equal or lower than 20. The expression has to be intendedas opposed to “nutritional composition characterized by high Glycaemicload” which indicates a nutritional composition having a glycemic loadhigher than 20. For example, the glycemic load of such low glycaemicload nutritional composition may be in one embodiment lower or equal to19, lower or equal to 17, lower or equal to 15. In one embodiment, theglycaemic load has a value ranging from 15 to 20, for example from 16 to19.

The expression “carbohydrate-based ingredient” or “carbohydrate-basedingredients” in the context of the present invention indicates a foodingredient consisting of or comprising one or more carbohydrates. Nonlimiting examples of carbohydrate based ingredients are: cereal flours(for example whole grain or refined flour from maize, wheat, rice, oat),cereal starches (for example from maize, wheat, oat, rice) sugars[honey, monosaccharides (eg. Galactose, fructose, glucose),disaccharides (eg. Sucrose, lactose, isomaltulose, maltose)],oligosaccharides (fructo-oligosaccharides, galacto-oligosaccharides,gluco-oligosaccharides, maltodextrines), polysaccharides (eg. resistantstarches), fibers (soluble and insoluble), pulses [for example Greenlentils, red lentils, yellow lentils, mung bean, cow peas, chick peas,butter bean, black eye bean, kidney bean, pea, pigeon pea, soya bean,haricot & navy beans, blacked bean, Soybean, Pea, Lupin, Faba bean, MungBeans, Chickpeas, Cowpea, Lentils (red, yellow, green), Carob, Beanswhite/green/black/red, Navy beans, Lima beans, Pinto beans, Pigeon Pea,Black gram, Carioguinha beans, Bambara bean (Vigna subterranean), Yambean, Canola flour, Flaxseed Powder, Chestnut flour], fruit, milk-basedingredients (for example powder skimmed or whole milk).

The expressions “sugar” or “sugars” within the context of the presentinvention comprises available monosaccharides (eg. Galactose, fructose,glucose) available disaccharides (eg. Sucrose, lactose, isomaltulose,maltose) or mixtures thereof.

Within the context of the present invention the term “added sugar”indicates an ingredient mainly or totally constituted by sugar which isadded to the complementary nutritional composition and whose content insugar contributes to the total sugar content of the composition.

The total sugar content of the complementary nutritional composition isprovided by the sum of amount of sugar naturally present in ingredientsused in the recipe (for example from cereal flour), those possiblyproduced during processing plus amount of added sugar. As it will beapparent to the person skilled in the art, the total amount of sugarswill also comprise any sugar amount which may be released by ingredientsused in the recipe during processing due to the specific conditions used(for example comprising partial hydrolysis of starch). Determination oftotal sugars in the complementary nutritional composition according tothe invention may be carried out according to methods well known to theperson skilled in the art.

For example, for quantification of total sugars in Infant cerealsproducts the following method can be used:

The quantification of mono- and disaccharides in infant cereal samplescan be completed by weighing a 1-3±0.001 gram sample into a 100 mLvolumetric flask and 60 milliliters of demineralized water were added.Mono- and disaccharides contained in the samples are extracted byplacing the flasks into a 70° C. water bath for 20 min with constantagitation. Samples are cooled to room temperature and more demineralizedwater is added to make up the mark on each volumetric flask, stoppersplaced and closed flasks were shaken vigorously. Samples are thenfiltered through folded filter paper (N^(o) 597, 150 mm Ø) and through a0.2 μm HPLC-filter before injection (25 mm Ø, 8825-P-2 Infochroma AG). Asolution containing monomeric glucose, dimeric lactose, sucrose,maltose, isomaltulose, and maltooligosaccharides having a degree ofpolymerization ranging from 3-7 is prepared as standard for peakidentification and saccharide quantification.

Filtered samples are injected into chromatograph after degassing theeluents (demineralized water, 18 MΩ·cm minimum; 300 mM NaOH; 500 mM NaOHwith 150 mM NaOAc) by sparging helium for 20-30 min and allowing thesystem to equilibrate. The following chromatographic conditions may beused: CarboPac PA1 (Dionex) column and guard column; 20 μL injectionvolume; 300 mM NaOH eluent with 0.6 mL/min flow rate as post columnaddition; 22° C. temperature.

The expression “milk-based ingredient” or “milk-based ingredients” inthe context of the present invention identifies carbohydrate containingingredients derived from mammal milk for example cow, goat and/orbuffalo or mixtures thereof. Non limiting examples of such ingredientscomprise: fresh milk, concentrated milk, powder milk, whole milk,skimmed and/or semi-skimmed milk.

As it will be apparent to the skilled person, milk-based ingredientsaccording to the present invention may bring additional nutrients beyondcarbohydrates to the complementary nutritional composition, such as forexample proteins and fats.

Within the context of the present invention the term “added sugar withlow glycemic index” indicates added sugar as above defined which ischaracterized by having a low glycaemic index. For the sake of clarity,the amount of lactose contained in any milk-based ingredient used in therecipe, will also account as added sugar with low glycaemic index.

The expressions “fiber” or “fibers” or “dietary fiber” or “dietaryfibers” within the context of the present invention indicate theindigestible portion, in small intestine, of food derived from plantswhich comprises two main components: Soluble fiber, which dissolves inwater and insoluble fiber. Mixtures of fibers are comprised within thescope of the terms above mentioned. Soluble fiber is readily fermentedin the colon into gases and physiologically active byproducts, and canbe prebiotic and viscous. Insoluble fiber does not dissolve in water, ismetabolically inert and provides bulking, or it can be prebiotic andmetabolically ferment in the large intestine. Chemically, dietary fiberconsists of non-starch polysaccharides such as arabinoxylans, cellulose,and many other plant components such as resistant starch, resistantdextrins, inulin, lignin, chitins, pectins, beta-glucans, andoligosaccharides. Non limiting examples of dietary fibers are: prebioticfibers such as Fructo-oligosaccharides (FOS), inulin,galacto-oligosaccharides (GOS), fruit fiber, vegetable fiber, cerealfiber, resistant starch such as high amylose corn starch. As fibers arenot digestible, they do not contain available carbohydrates and on thisbasis they do not contribute to the GI or GL of the composition they'repart of.

Within the context of the present invention the term “added fiber” or“added dietary fiber” indicates an ingredient mainly or totallyconstituted by fiber which is added to the complementary nutritionalcomposition and whose content in fiber contributes to the total fibercontent of the composition. The total fiber content of the complementarynutritional composition is provided by the sum of amount of fibernaturally present in ingredients used in the recipe (for example fromwhole grain cereal flour) plus amount of added fiber.

Within the context of the present invention, the term “legume” or“legumes” identifies the fruit or seed of a plant in the family ofFabaceae or mixtures thereof. Well-known legumes include inter aliaalfalfa, clover, peas, beans, lentils, lupins, mesquite, carob,soybeans, peanuts and tamarind. The grain seeds of such plants aregenerally known as “pulses” and are comprised within the scope of theterm “legumes” according to the present invention.

As it will be apparent to the skilled person, legumes according to thepresent invention may bring additional nutrients beyond carbohydrates tothe complementary nutritional composition, such as for example vitamins,minerals, proteins of vegetable origin and/or fibers.

Within the context of the present invention, the term “fruit” or“fruits” indicates ingredients derived from fruit such as for examplefresh fruit, fruit paste, dried fruit, fruit extracts and/orcentrifugates. Mixtures of such ingredients are also comprised withinthe scope of the terms above mentioned. Non limiting examples of fruitaccording to the present invention are: apple, apricot, banana, cherry,pear, strawberry, Mango, Orange, peach.

The expression “carbohydrate-based ingredient with low glycemic index”in the context of the present invention indicates a carbohydrate-basedingredient having a glycemic index equal or lower than 70. For example,the glycemic index of such carbohydrate-based ingredient may be in oneembodiment lower or equal to 65, lore or equal to 60, lower or equal to55, lower or equal to 50, lower or equal to 45.

Non limiting examples of carbohydrate based ingredients with lowglycemic index may be: cereal flours (for example whole grain or refinedflour from maize, wheat, rice, oat), sugars [monosaccharides (eg.Galactose, fructose), disaccharides (eg. Sucrose, lactose,isomaltulose), oligosaccharides (fructo-oligosaccharides,galacto-oligosaccharides, gluco-oligosaccharides)], polysaccharides (eg.resistant starches), fibers (soluble and insoluble), legumes [especiallypulses for example Green lentils, red lentils, yellow lentils, mungbean, cow peas, chick peas, butter bean, black eye bean, kidney bean,pea, pigeon pea, soya bean, haricot & navy beans, blacked bean, Soybean,Pea, Lupin, Faba bean, Mung Beans, Chickpeas, Cowpea, Lentils (red,yellow, green), Carob, Beans white/green/black/red, Navy beans, Limabeans, Pinto beans, Pigeon Pea, Black gram, Potato protein isolate,Carioguinha beans, Bambara bean (Vigna subterranean), Yam bean, Canolaflour, Sunflower protein, Hemp, Flaxseed Powder, Chestnut flour], fruit(for example dried fruit or fruit paste), milk-based ingredients, suchas powder skimmed or whole milk.

The glycemic index of low glycemic index sugars is in one embodiment ofthe present invention lower or equal to 70, lower or equal to 60, loweror equal to 45, lower or equal to 35, lower or equal to 30. In oneembodiment, the GI of low glycemic index sugars is ranging from 0 to 55,for example from 0 to 40. In one embodiment, sugar is selected forexample from the group consisting of: Galactose, fructose, Sucrose,lactose and isomaltulose.

The glycemic index of legumes is in one embodiment of the presentinvention lower or equal to 55, lower or equal to 50, lower or equal to45, lower or equal to 35, lower or equal to 30. In one embodiment, theGI of legumes is ranging from 15 to 40, for example from 20 to 35.

The glycemic index of milk-based ingredients is in one embodiment of thepresent invention lower or equal to 55, lower or equal to 50, lower orequal to 45, lower or equal to 35. In one embodiment, the GI ofmilk-based ingredients is ranging from 20 to 40, for example from 25 to35.

The glycemic index of fruit is in one embodiment of the presentinvention lower or equal to 55, lower or equal to 50, lower or equal to45, lower or equal to 35, lower or equal to 30. In one embodiment, theGI of legumes is ranging from 15 to 40, for example from 20 to 35. Inone embodiment, fruit is dried fruit selected for example from the groupconsisting of: apple, apricot, banana, cherry, pear, strawberry, Mango,Orange and peach.

The expression “fat” or “fat source” or “lipid” or “lipid source” or“fats” in the context of the present invention indicates an edible solidor liquid fat or mixtures thereof. Not limiting categories of fats arethose from animal, fish or vegetable origins. Non limiting examples offats which could be used according to the present invention are: fishoil, cocoa butter, cocoa butter equivalents (CBE), cocoa buttersubstitutes (CBS), vegetable oils (for example rapeseed oil, palm oil,corn oil, soy oil, coconut oil and/or sunflower oil) and butter oilsamongst others.

Within the context of the present invention, the term “complementarynutritional set” indicates all the food, either in liquid or solid form,which is ingested by an infant or young child on a daily basis duringthe complementary feeding period. According to the present invention,the complementary nutritional set comprises a complementary nutritionalcomposition characterized by and/or comprising an ingredient with a lowglycaemic index. In one embodiment, the complementary nutritionalcomposition according to the present invention provides at least 10%,for example 20%, or 30%, or 50%, or 70% or 90% of the total caloriccontent of the complementary nutritional set wherein it is comprised.

In the context of the present invention, where amounts of certainingredients (such as, for example, sugars, fats, dietary fibers etc),are indicated which may result from different constituents incorporatedin the recipe then such amounts will reflect the total content of thatingredient in the composition, irrespective of the component it isderived from.

On the other hand, when in the present invention reference is made to an“added” ingredient (such as for example added fibers, added sugars withlow glycemic index etc), then only the amount of the component mainly ortotally constituted by that ingredient should be accounted in thecalculation.

Composition for Use

The invention in a first aspect relates to a complementary nutritionalcomposition characterized by a low glycemic load for use in treatment,prevention and/or reducing the risk of a metabolic syndrome disorderappearing later in life.

The invention also relates to a complementary nutritional compositioncharacterized by a low glycemic index for use in treatment, preventionand/or reducing the risk of a metabolic syndrome disorder appearinglater in life.

The invention also relates to a complementary nutritional compositioncharacterized by a low glycemic load and index for use in treatment,prevention and/or reducing the risk of a metabolic syndrome disorderappearing later in life.

In one embodiment of the present invention, the complementarynutritional composition is characterized by eliciting a low glucoseresponse in the subject assuming it.

In one embodiment of the present invention, the complementarynutritional composition is characterized by eliciting a low insulinresponse in the subject assuming it.

In one embodiment of the present invention, the complementarynutritional composition is characterized by eliciting a low glucose andinsulin response in the subject assuming it.

In one embodiment of the present invention, complementary nutritionalcomposition characterized by a low glycaemic index is achieved byreducing the quantity of a carbohydrate-based ingredient by any mean.

In another aspect, the complementary nutritional composition of thepresent invention comprises at least one ingredient with low glycemicindex.

In one embodiment, the complementary nutritional composition accordingto the present invention comprises one cereal flour or mixtures thereof.In one embodiment, the cereal flour may be refined or whole grain. In afurther embodiment, the cereal flour may be refined or whole grainmaize, wheat, rice, oat, corn or barley flour.

In one embodiment, the complementary nutritional composition of thepresent invention comprises an amount of cereal flours ranging from 20to 90% w/w, for example 20 to 70% w/w.

In one embodiment, when the complementary nutritional composition is aninfant cereal product, for example a complete infant cereal product, itcomprises an amount ranging from 30 to 55% w/w of cereal flours. In oneembodiment, it comprises 0 to 30% w/w of refined flour and 0 to 55% ofwhole grain flours.

In one embodiment, when the complementary nutritional composition is aninfant cereal product, for example a standard infant cereal product, itcomprises an amount ranging from 40 to 85% w/w or 50 to 90% w/w ofcereal flours. In one embodiment, it comprises 30 to 50% w/w of refinedflour and 20 to 40% of whole grain flours.

In one embodiment, the complementary nutritional composition of thepresent invention comprises at least one carbohydrate-based ingredientwith low glycemic index.

In a further embodiment, the complementary nutritional composition ofthe present invention comprises at least one carbohydrate-basedingredient selected from the group consisting of: Resistant starches,Amylose, Sucrose, Lactose, Isomaltulose, Maltitol, Galactose, Fructose,Isomalt, Xilitol and Polydextrose.

In one embodiment, the complementary nutritional composition of thepresent invention comprises a sugar or mixtures thereof.

In one embodiment, the total amount of sugars in the complementarynutritional composition according to the invention ranges from 0 to 30%w/w, preferably from 0 to 20, for example between 5 to 18% w/w.

In one embodiment, for example when the product is an infant cerealcomplete product, the total amount of sugars in the complementarynutritional composition according to the invention ranges from 0 to 30%w/w, preferably from 2 to 25, for example between 5 to 25% w/w.

In one embodiment, for example when the product is an infant cerealstandard product, the total amount of sugars in the complementarynutritional composition according to the invention ranges from 0 to 30%w/w, preferably from 2 to 25, for example between 5 to 20% w/w.

In another embodiment, the amount of added sugars in the complementarynutritional composition ranges from 0 to 30% w/w, for example from 1 to20% w/w or from 5 to 15% w/w.

In one embodiment, the complementary nutritional composition of thepresent invention comprises an amount of added sugars with low glycemicindex which ranges from 0 to 30% w/w, for example from 1 to 20% w/w orfrom 5 to 15% w/w. For example the low glycemic index sugar may beselected in the group consisting of: lactose, galactose, fructose, andisomaltulose.

In one embodiment, the complementary nutritional composition of theinvention comprises an edible fat or mixtures thereof, for example itcomprises vegetable oils (for example rapeseed oil, palm oil, corn oil,soy oil, coconut oil and/or sunflower oil) and/or fats derived frommilk.

In a further embodiment, the complementary nutritional compositioncomprises fats in an amount ranging from 8 to 20% w/w of thecomposition, for example ranging from 10 to 20% w/w, for example rangingfrom 10 to 17% w/w or from 10 to 15% w/w.

In one embodiment, the energy provided by fats in the composition rangesfrom 22 to 40%, for example between 27 and 38% of the total energyintake provided by the complementary composition according to theinvention.

In one embodiment, the complementary nutritional composition accordingto the present invention doesn't comprise fats. In such embodiment, thecomplementary nutritional composition of the invention may be a standardcereal product as above defined.

In one embodiment, the complementary nutritional composition accordingto the invention comprises a dietary fiber or mixtures thereof. In oneembodiment, the total amount of dietary fibers in the complementarynutritional composition according to the invention ranges from 0 to 25%w/w, for example from 2 to 22% w/w; for example from 2 to 12% w/w, forexample from 6 to 10% w/w.

In another embodiment, when the complementary nutritional composition isa complete infant cereal product, the amount of added fibers in thecomplementary nutritional composition ranges from 0 to 10% w/w, forexample from 1 to 8% w/w or from 1.5 to 7% w/w.

In a further embodiment, when the complementary nutritional compositionis a standard infant cereal product, the amount of added fibers in thecomplementary nutritional composition ranges from 0 to 20% w/w, forexample from 5 to 18% w/w.

In one embodiment, the complementary nutritional composition accordingto the present invention comprises a milk-based ingredient or mixturesthereof.

In one embodiment, the complementary nutritional composition comprises amilk-based ingredient in an amount ranging from 0 to 35% w/w, forexample 0 to 30% w/w, for example from 1 to 25% w/w, for example from 5to 25% w/w.

In a further embodiment, the complementary nutritional compositioncomprises milk-based ingredients having a GI lower or equal to 30 in anamount ranging from 0 to 35% w/w, for example 0 to 30% w/w, for examplefrom 1 to 25% w/w, for example from 5 to 25% w/w.

In one embodiment, the complementary nutritional composition accordingto the present invention comprises a legume or mixtures thereof.

In one embodiment, the complementary nutritional composition compriseslegumes in an amount ranging from 5 to 40% w/w, for example from 8 to30% w/w, for example from 10 to 25% w/w.

In a further embodiment, the complementary nutritional compositioncomprises legumes having a GI lower or equal to 50 in an amount rangingfrom 5 to 40% w/w, for example from 8 to 30% w/w, for example from 10 to25% w/w.

In one embodiment, the complementary nutritional composition accordingto the present invention comprises a fruit or mixtures thereof.

In one embodiment, the complementary nutritional composition comprisesfruits in an amount ranging from 0 to 25% w/w, for example from 1 to 18%w/w.

In a further embodiment, the complementary nutritional compositioncomprises fruits having a GI lower or equal to 70, for example lower orequal to 50 in an amount ranging from 0 to 20% w/w, for example from 1to 15% w/w.

In one embodiment, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 25% w/w;    -   added fiber in amount ranging from 0 to 20% w/w;    -   milk-based ingredient in an amount ranging from 0 to 30% w/w,        for example from 1 to 25% w/w, for example from 5 to 25% w/w;    -   legume in amount ranging from 0 to 40%, for example from 5 to        40% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In one embodiment, the above described complementary nutritionalcomposition is characterized by a low glycemic index and/or a lowglycemic load. In one embodiment, the above described complementarynutritional composition of the invention is an infant cereal product. Inone embodiment, the above described complementary nutritionalcomposition is characterized by eliciting a low glucose and/or insulinresponse in the subject assuming it. In one embodiment, the abovedescribed complementary nutritional composition of the invention is foruse in treatment, prevention and/or reducing the risk of a metabolicsyndrome disorder appearing later in life.

In one embodiment, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 70% w/w, for example        30 to 55% w/w of cereal flours;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 2 to 12%        w/w, for example from 6 to 10% w/w;    -   added fiber in amount ranging from 0 to 10% w/w, for example        from 1 to 8% w/w, for example from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 0 to 35% w/w,        for example 0 to 30% w/w, for example from 1 to 25% w/w, for        example from 5 to 25% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 8        to 30% w/w, for example from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In another embodiment, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 70% w/w, for example        30 to 55% w/w of cereal flours, for example 33 to 50% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        25% w/w, for example from 5 to 25% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 2 to 12%        w/w, for example from 6 to 10% w/w;    -   added fiber in amount ranging from 0 to 10% w/w, for example        from 1 to 8% w/w, for example from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 0 to 35% w/w,        for example from 0 to 30% w/w, for example from 1 to 25% w/w,        for example from 5 to 25% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 5        to 40% w/w, for example from 8 to 30% w/w, for example from 10        to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In an additional embodiment, the present invention provides acomplementary nutritional composition comprising:

-   -   cereal flour in amount ranging from 33 to 50% w/w;    -   sugar in amount ranging from 5 to 25% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 10 to 17% w/w;    -   total amount of dietary fiber in amount ranging 6 to 10% w/w;    -   added fiber in amount ranging from 0 to 10% w/w, for example        from 1 to 8% w/w, for example from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 5 to 25% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 5        to 40% w/w, for example from 8 to 30% w/w, for example from 10        to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 33 to 50% w/w;    -   sugar in amount ranging from 5 to 25% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 10 to 17% w/w;    -   total amount of dietary fiber in amount ranging from 6 to 10%        w/w;    -   added fiber in amount ranging from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 5 to 25% w/w;    -   legume in amount ranging from 10 to 25% w/w;    -   fruit in an amount ranging from 1 to 18% w/w;    -   wherein the complementary nutritional composition comprises 0 to        30% w/w of cereal refined flour and 0 to 55% of cereal whole        grain flours.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 33 to 50% w/w;    -   sugar in amount ranging from 5 to 25% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 10 to 17% w/w;    -   total amount of dietary fiber in amount ranging from 6 to 10%        w/w;    -   added fiber in amount ranging from 0 to 10% w/w, for example        from 1 to 8% w/w, for example from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 5 to 25% w/w;    -   legume in amount ranging from 10 to 25% w/w;    -   fruit in an amount ranging from 1 to 18% w/w;    -   wherein the complementary nutritional composition comprises 0 to        30% w/w of cereal refined flour and 0 to 55% of cereal whole        grain flours.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 33 to 50% w/w;    -   sugar in amount ranging from 5 to 25% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 10 to 17% w/w;    -   total amount of dietary fiber in amount ranging from 6 to 10%        w/w;    -   added fiber in amount ranging from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 5 to 25% w/w;    -   legume in amount ranging from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.    -   wherein the complementary nutritional composition comprises 0 to        30% w/w of cereal refined flour and 0 to 55% of cereal whole        grain flours.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 33 to 50% w/w;    -   sugar in amount ranging from 5 to 25% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 10 to 17% w/w;    -   total amount of dietary fiber in amount ranging from 6 to 10%        w/w;    -   added fiber in amount ranging from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 5 to 25% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 5        to 40% w/w, for example from 8 to 30% w/w, for example from 10        to 25% w/w;    -   fruit in an amount ranging from 1 to 18% w/w;    -   wherein the complementary nutritional composition comprises 0 to        30% w/w of cereal refined flour and 0 to 55% of cereal whole        grain flours.

In one embodiment, the above described seven complementary nutritionalcompositions are characterized by a low glycemic index and/or a lowglycemic load. In one embodiment, the above described complementarynutritional composition of the invention is a complete infant cerealproduct. In one embodiment, the above described complementarynutritional composition is characterized by eliciting a low glucoseand/or insulin response in the subject assuming it. In one embodiment,the above described complementary nutritional composition of theinvention is for use in treatment, prevention and/or reducing the riskof a metabolic syndrome disorder appearing later in life.

In another embodiment, the present invention provides a complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        40 to 85% w/w of cereal flours;    -   total sugar in amount ranging from 0 to 30% w/w, for example        from 0 to 20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 0 to 10% w/w of the composition,        for example ranging from 0 to 8% w/w, for example from 0 to 5%        w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 22% w/w;    -   added fiber in amount ranging from 0 to 20% w/w, for example        from 5 to 18% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 8        to 30% w/w, for example from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In another embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        40 to 85% w/w, for example for example 50 to 90% w/w of cereal        flours;    -   total sugar in amount ranging from 0 to 30% w/w, for example        from 5 to 25% w/w, for example from 0 to 20% w/w, for example        from 2 to 20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 0 to 10% w/w of the composition,        for example ranging from 0 to 5% w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 22% w/w;    -   added fiber in amount ranging from 0 to 20% w/w, for example        from 5 to 18% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 8        to 30% w/w, for example from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 50 to 90% w/w;    -   total sugar in amount ranging from 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 0 to 10% w/w of the composition,        for example ranging from 0 to 5% w/w;    -   total amount of dietary fiber in amount ranging from 2 to 22%        w/w;    -   added fiber in amount ranging from 0 to 20% w/w, for example        from 5 to 18% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 8        to 30% w/w, for example from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w.

wherein the complementary nutritional composition comprises 30 to 50%w/w of cereal refined flour and 20 to 40% of cereal whole grain flours.

In a further embodiment, the present invention provides complementarynutritional composition comprising:

-   -   cereal flour in amount ranging from 50 to 90% w/w;    -   total sugar in amount ranging from 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 5 to        15% w/w;    -   fat in an amount ranging from 0 to 10% w/w of the composition,        for example ranging from 0 to 5% w/w;    -   total amount of dietary fiber in amount ranging from 2 to 22%        w/w;    -   added fiber in amount ranging from 5 to 18% w/w;    -   legume in amount ranging from 10 to 25% w/w;    -   fruit in an amount ranging from 1 to 18% w/w;

wherein the complementary nutritional composition comprises 30 to 50%w/w of cereal refined flour and 20 to 40% of cereal whole grain flours.

In one embodiment, the above described three complementary nutritionalcompositions are characterized by a low glycemic index and/or a lowglycemic load. In one embodiment, the above described complementarynutritional composition of the invention is a standard infant cerealproduct. In one embodiment, the above described complementarynutritional composition is characterized by eliciting a low glucoseand/or insulin response in the subject assuming it. In one embodiment,the above described complementary nutritional composition of theinvention is for use in treatment, prevention and/or reducing the riskof a metabolic syndrome disorder appearing later in life.

In a further embodiment, the present invention provides a complementarynutritional set which comprises a complementary nutritional compositioncomprising:

-   -   cereal flour in amount ranging from 20 to 70% w/w, for example        30 to 55% w/w of cereal flours, for example 33 to 50% w/w;    -   sugar in amount ranging from 0 to 30% w/w, for example from 0 to        25% w/w, for example from 5 to 25% w/w, for example from 0 to        20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 8 to 20% w/w of the composition,        for example ranging from 10 to 17% w/w, for example from 10 to        15% w/w;    -   total amount of dietary fiber in amount ranging from 2 to 12%        w/w, for example from 6 to 10% w/w;    -   added fiber in amount ranging from 0 to 10% w/w, for example        from 1 to 8% w/w, for example from 1.5 to 7% w/w;    -   milk-based ingredient in an amount ranging from 0 to 35% w/w,        for example from 0 to 30% w/w, for example from 1 to 25% w/w,        for example from 5 to 25% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 5        to 40% w/w, for example from 8 to 30% w/w, for example from 10        to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w;

OR

-   -   cereal flour in amount ranging from 20 to 90% w/w, for example        40 to 85% w/w, for example for example 50 to 90% w/w of cereal        flours;    -   total sugar in amount ranging from 0 to 30% w/w, for example        from 5 to 25% w/w, for example from 0 to 20% w/w, for example        from 2 to 20% w/w, for example between 5 to 18% w/w;    -   added sugar with low glycemic index in amount ranging from 0 to        30% w/w, for example from 1 to 20% w/w, for example from 5 to        15% w/w;    -   fat in an amount ranging from 0 to 10% w/w of the composition,        for example ranging from 0 to 8% w/w, for example from 0 to 5%        w/w;    -   total amount of dietary fiber in amount ranging from 0 to 25%        w/w, for example from 2 to 22% w/w;    -   added fiber in amount ranging from 0 to 20% w/w, for example        from 5 to 18% w/w;    -   legume in amount ranging from 5 to 40% w/w, for example from 8        to 30% w/w, for example from 10 to 25% w/w;    -   fruit in an amount ranging from 0 to 25% w/w, for example from 1        to 18% w/w;

OR

Any of the above described complementary composition according to thepresent invention.

Composition for Use—Disorders

The invention relates to a complementary nutritional compositionaccording to the present invention for use in treatment, preventionand/or reducing the risk of a metabolic syndrome disorder later in life.

In one embodiment, the invention relates to a complementary nutritionalcomposition according to the present invention for use in preventionand/or reducing the risk of a metabolic syndrome disorder later in life.

The term “metabolic syndrome disorder” as used herein refers to one ormore disorders associated with Metabolic Syndrome. Examples of suchdisorders include diabetes such as diabetes mellitus, impaired glucosetolerance, impaired fasting glucose, insulin resistance, hypertension,dyslipidemia, overweight, obesity (particularly central obesity) andmicroalbuminuria. These disorders are typically a result of adysregulation of the glucose homeostasis. For example, the disorder canbe selected in the group consisting of: diabetes mellitus, impairedglucose tolerance, impaired fasting glucose, insulin resistance,hypertension, overweight and obesity (particularly central obesity).

Thus the invention relates in one embodiment to the composition for useaccording to the invention wherein the disorder is selected from thegroup consisting of diabetes mellitus, impaired glucose tolerance,impaired fasting glucose, insulin resistance, hypertension,dyslipidemia, overweight, obesity (particularly central obesity) andmicroalbuminuria.

In other embodiments, the invention relates to the composition for useaccording to the invention, wherein the use is to improve insulinsensitivity, to promote normal weight and/or to prevent overweight laterin life.

The term “later in life” in the context of the present invention refersto the period of time after childhood, that is after 12 years of age. Inembodiments of the invention, the metabolic syndrome disorder appearsafter 12 years of age, or for example after 15 years of age, such asafter 18 years of age, such as after 25 years of age, after 30 years ofage, after 35 years of age.

Accordingly, a further embodiment of the invention relates to acomposition for use according to the invention wherein the use is intreatment, prevention and/or reducing the risk of a metabolic syndromedisorder appearing later in life when exposed to an adipogenic diet.

The term “adipogenic diet” in the context of the present inventionrelates to a diet which will lead to increased fat mass of theindividual. Generally speaking, an excess of energy intake will lead toincreased fat mass, therefore one example of an adipogenic diet is adiet where the caloric intake exceeds the individual's required caloricneed. Other examples of an adipogenic diet include the typical Westerndiet, also known as the western pattern diet or Standard American Diet.Another example of an adipogenic diet is where the diet is characterizedby a fat content that exceeds the dietary recommendation of 30% of theenergy from fat, high sugar diet and/or that the caloric intake exceedsthe individual's required caloric need.

Thus, it is envisaged that the composition for use according to theinvention, when administered early in life (for example to an infant notyounger than 4 months or young child), will protect that individual ifand when said individual later in life (for example as an adult, or forexample after 18, after 20, after 25, after 30 years of age) eats a dietwhich is adipogenic. By protect, it is meant that glucose homeostasisand/or insulin sensitivity will not be impaired, or will be not beimpaired to same extent. Without being bound by the theory, it ishypothesised that the use of the composition of the invention, at thetime of administration, modulates the metabolic pathways.

In other embodiments, the invention relates to the composition for useaccording to the invention, wherein the use is to improve insulinsensitivity, to promote normal weight and/or to prevent overweight.

Composition for Use—Target Groups

The composition for use according to the invention is to be administeredto an infant not younger than 4 months or to a young child.

In one embodiment the infant or young child is for example born to amother who herself suffered or suffers from one or more metabolicsyndrome disorders, such as one or more selected from the groupconsisting of diabetes mellitus, impaired glucose tolerance, impairedfasting glucose, insulin resistance, hypertension, dyslipidemia,overweight, obesity (particularly central obesity) and microalbuminuria,or from gestational diabetes.

In a further embodiment the infant or young child is deemed to be atrisk for one or more metabolic syndrome disorders, for example due to afamilial risk, such as family history, preterm birth, low weight atbirth and/or growth restriction.

In one embodiment, the composition for use is to be administered to aninfant not younger than 4 months or young child, regardless of birthweight.

In another embodiment of the present invention, the composition for useaccording to the invention is to be administered to an infant notyounger than 4 months, for example 6 months, or young child whose birthweight was normal. In another embodiment the birth weight of the infantor young child was below or above normal.

In a further embodiment, the present invention relates to a compositionfor use according to the invention, wherein the composition is to beadministered to an infant not younger than 4 months, for example 6months, or young child who underwent a period of catch-up growthfollowing a period of growth restriction.

In a further embodiment, the present invention relates to a compositionfor use according to the invention, wherein the composition is to beadministered to an infant not younger than 4 months, for example 6months, or young child who has not undergone a period of catch-up growthfollowing a period of growth restriction.

In yet a further embodiment, the present invention relates to acomposition for use according to the invention, wherein the compositionis to be administered to infant not younger than 4 months, for example 6months, or young child who was born with normal birth weight and with anon-restricted food intake and normal growth during infancy and/or youngage.

Dosage Regimen

The invention relates to the surprising finding that administration oflow glycaemic index nutritional compositions to an infant or young childof an age comprised between 4, for example 6, months and 5, for example2, years can protect from metabolic syndrome disorders later in life.

The complementary composition for use according to the invention is tobe administered to the infant or young child in a time period from 4 to60 months. In other embodiments, the administration falls in a timeperiod from 6 months to 36 months, or 24 months, such as to 18 months,for example to 12 months.

In one embodiment of the present invention, the composition for useaccording to the invention is administered to an infant or young childduring the complementary feeding period.

The complementary feeding period refers to the period in an infant's oryoung child's life where they are transitioned from exclusive milkfeeding (such as breast milk feeding) to mix diet comprising breast milk(or replacers) and solid foods. This period depends on the individualinfant or young child, but typically falls within the range from 4months to 18 months of age, such as from 6 to 18 months.

In one embodiment of the present invention, the complementarycomposition for use according to the invention is to be administered toan infant or young child of an age comprised between 4 to 60 months andadministration should last for at least 3 months, for example 6 monthsor 9 months or 12 months.

In the above mentioned period administration may be for exampleintermittent, or for example on average once daily over said the period,or for example once every other day over said period, or for example atleast once daily during said period.

In another embodiment of the present invention, the administration ofthe composition is for a shorter duration of time falling within thetime period mentioned above, for example on average once daily for aduration of at least six weeks in said time period; such as for exampleon average once daily for 3, 6, 8, 9 months during said time period.

Alternatively, the administration may be for example on average onceevery other day for a period of at least six weeks in the period from 4months to 60 months, such as for example on average once every other dayfor a period of 3, 6, 8, or 9 months during said time period.

In other embodiments the invention relates to a use according to theinvention, wherein a composition is administered at least once a day forat least 1 month.

In one embodiment of the present invention, the complementarynutritional composition provides to the infant or young child assumingit at least 10%, for example 20%, or 30%, or 50%, or 70%, or 80%, of thetotal daily caloric intake.

In another embodiment, the complementary nutritional compositionprovides to the infant or young child assuming the total daily caloricintake.

Nutritional Composition Formats

A medical food is a special class of nutritional composition designed toprovide dietary management of certain conditions. The medical food meetscertain criteria as set out by and regulated under the Orphan Drug Actof 1983 in Section 5 [360ee](b)(2)(D). The medical food may be presentedin any suitable format, as discussed below.

Thus, one embodiment of the invention relates to a complementarynutritional composition according to the invention wherein thenutritional composition is a medical food.

The complementary nutritional composition according to the invention maybe in any suitable format.

The format of the complementary nutritional composition for useaccording to the invention may be tailored to suit the age of the infantor young child to whom it is administered.

Examples of nutritional composition formats suitable for infants includea follow-on formula, a growing up milk, an infant cereal product or ababy food.

Examples of formats suitable for infants and/or young children includeready-to-drink compositions, liquid comestibles, milk drinks,milk-shakes, milk-biscuits, yoghurts, soups, desserts, puddings, barssuch as cereal bars, extruded cereals, porridges, beverages and babyfoods.

When the complementary nutritional composition is an infant cerealproduct, it may comprise at least 0.48 g/100 kJ of a protein source, atmost 1.1 g/100 kJ of a lipid source and a carbohydrate source.

Infant cereals are known in the art. Infant cereals are compositionscontaining cereals to be administered to infants. They are usually to beadministered using a spoon, and may be offered as dry cereal forinfants, for example. Also ready to serve infant cereals are within thescope of the present invention. The codex alimentarius offers guidanceon what ingredients an infant cereal should contain. Infant cereals maybe intended to be reconstituted either in water or in milk.

Typically, the caloric density as well as the amounts and kinds ofproteins, carbohydrates and lipids present in the infant cereal shouldbe carefully adjusted to the needs of the infant and are dependent onthe infant stage of development and age.

It is well known that the requirements for nutrition of an infantchanges with the development and age of the infant, and the compositionof the infant cereal ideally reflects this change.

Hence, a standard infant cereal (to be prepared with milk) according tothe present invention to be to be administered to infants at the age of4-6 months may have an energy density of 220-240 kJ/15 g, 0.8-1.2 g/15 gof a protein source, 0.1-0.3 g of a fat source and 12.3-12.7 g/15 g of acarbohydrate source. Such an infant cereal may contain, for example,Rice flour, Maize Maltodextrin, Vitamin C, and Iron.

A standard infant cereal (to be prepared with milk) according to thepresent invention to be to be administered to infants at the age of 6-12months may have an energy density of 220-240 kJ/15 g, 1.5-1.9 g/15 g ofa protein source, 0.2-0.4 g of a fat source and 11.1-11.5 g/15 g of acarbohydrate source. Such an infant cereal may contain, for example,Wheat flour, Semolina from wheat, Iron, Vitamin C, Niacin, Vitamin B6,Thiamin, and Maize Maltodextrin.

Hence, an infant cereal to be prepared with water according to thepresent invention to be administered to infants from the age of 4-6months may have per 100 g, energy density of 400-420 kcal 100 g, 10-16 gof a protein source, 7-17 g of a fat source and 50-75 g of acarbohydrate source. Such an infant cereal may contain, for example,Rice flour, Maize Maltodextrin, Vitamin C, and Iron.

An infant cereal according to the present invention to be to beadministered to infants at the age of 6-12 months may have an energySuch an infant cereal may contain, for example, Wheat flour, Semolinafrom wheat, Iron, Vitamin C, Niacin, Vitamin B6, Thiamin, and MaizeMaltodextrin.

Infant cereals may be prepared from one or more milled cereals, whichmay constitute at least 25 weight-% of the final mixture on a dry weightbasis.

The infant cereals of the present invention are preferably prepared froma single grain—like rice cereal or wheat cereal—because single graincompositions are less likely to cause an allergic reactions.

Typically, infants cereals are to be mixed with water or milk beforeconsumption. For example 15 g of a infant cereal of the presentinvention may be to be mixed with 45 mL (complete infant cereal) ofwater or 90 ml of milk (standard infant cereal) respectively.

Combination of Disclosures

It should be noted that embodiments and features described in thecontext of one of the aspects of the present invention also apply to theother aspects and embodiments of the invention mutatis mutandis.

The compositions for use according to the invention are herein describedby different parameters, such as the ingredients, nutritionalcomposition formats, uses, target groups etc. It should be noted thatembodiments, features and exemplary embodiments described in the contextof one of the parameters of the composition for use according to theinvention, may also be combined with other embodiments, features andexemplary embodiments described in the context of another parameter,unless expressly stated otherwise.

All patent and non-patent references cited in the present application,are hereby incorporated by reference in their entirety.

The invention will now be described in further details in the followingnon-limiting examples.

EXPERIMENTAL SECTION Example 1

The effect of diets during complementary feeding period with differentGI on later blood glucose levels during adulthood was investigated,using a rat model of intrauterine growth retardation (IUGR). IUGR modelwas used as a sensitive model for later impaired glucose homeostasis(see Shankhalili Y. et Al, 2010, “Comparison of two models onintrauterine growth restriction for early catch up growth and laterdevelopment of glucose intolerance and obesity in rats” (Am. J. PhysiolRegul Interg Comp Physiol 298; R141-R146).

Study Design:

IUGR was induced in Sprague Dawley (SD) rats by 50% food restrictionduring last 10 days of gestation. The pups were fed with their damsduring suckling period. At the end of suckling period (age 21 d), 40male pups from the IUGR group and twenty male pups from the Non IUGRgroup (reference group) were separated from dams.

The IUGR pups were randomly divided into two groups (20/group) withsimilar body weight and same number of pups from each litter. The pupswere then fed ad-libitum from age of 21 to 52 d (phase I) with amodified semi-synthetic AIN96 complementary feeding diet with 15%glucose energy (E) and either 15% galactose E (galactose diet: G IUGRgroup) or 15% starch E (control diet: C non IUGR and C IUGR groups). Themicronutrients and fiber content and macronutrient energy partitioningof both complementary feeding diets were similar with 20% protein E, 17%fat E and 67% CHO E with presence or absence of 15% galactose E as anisocaloric exchange for the corn starch of control diet (Table 1).

Subsequently, all animals were fed ad-libitum with a high fat diet(Kliba 2126, 45% fat E) until age of 155 days (phase II). FIG. 1 showsthe design of study.

Food intake and body weight were recorded during the study (2-3times/week). The baseline blood samples (after 8 hr of fooddeprivation), were taken from the tail vein at age of 52 and 141 daysfor glucose and insulin analysis.

A surrogate of glycemic load for rats (SGL) based on a daily intake of15 g was calculated for the two diets proposed to the groups. For thecontrol diet SGL=7.1 while for the Galactose Diet SGL=5.76, resulting ina 19.2% reduction of SGL relative to the control diet.

TABLE 1 Composition of diets Ingredient Galactose Diet Control Diet Cornflour starch 33 48 K-casein 20 20 D-glucose 15 15 Galactose 15 — Soybeanoil 7 7 Cellulose 5 5 Mineral Mix 3.5 3.5 Vitamin Mix 1 1 Others 0.5 0.5Total (wet weight) 100 100 Kcal/100 g wet mixture 360.0 360.0 % EnergyProtein 20 20 CHO 62 62 Fat 18 18

Results

Body Weight and Energy Intake

Body weight of both IUGR groups was significantly lower than that of nonIUGR group at birth. However, IUGR group growth faster than non —IUGRgroup during first week of suckling period (catch up growth) and allgroups had similar body weight from age of 10 days (FIG. 2). Totalenergy intake (FIG. 3) and body weight (FIG. 4) of all groups were alsosimilar during both the intervention complementary feeding period (phaseI) and follow-up period (phase II).

Base Line Blood Glucose and Insulin

The results shows that both IUGR groups had lower blood glucose andinsulin baseline relative to non IUGR group at the end of thecomplementary feeding period (age of 51 days), indicating alteredglucose metabolism in IUGR rats and lack of immediate effect of thecomplementary feeding diet.

Surprisingly, the IUGR group who was previously fed with galactose (lowGI sugar), only during complementary feeding period (age of 21-51 days),had lower blood glucose later at adult age (age of 142 days) relative tocontrol IUGR group who was fed a complementary feeding diet higher instarch content (higher GI carbohydrate) (FIG. 4). The values of thegroup that received galactose during the complementary period werenormalized and resembled those of the reference group non-IUGR. Similartrend was also observed in insulin response at age of 142 days (FIG. 5).

In conclusion, these results shows for the first time that complementaryfeeding diets with different GI, GL have an impact on later bloodglucose/insulin control in the adult age and consequently on the risk ofdeveloping metabolic diseases. These findings thus indicate beneficialprogramming effect of low glycemic load and/or index complementaryfeeding diets on later control of glucose homeostasis and risk ofdevelopment of type 2 diabetes and other metabolic diseases later inlife.

Example 2

Example of Infant Cereal Product Prepared with Water (% Weight).

A traditional infant cereal product to be reconstituted in water isprepared according to the following recipe: Wheat flour 45% (40.1 gCHO), skim milk 26% (14.6 g CHO), oil 7%, glucose 6%, sucrose 15%,vitamin and minerals 1% The GI (calculated based on ingredient GI) ofthis example is 70 and GL of 24.6.

Calculation of Glycemic load (serving size of 50 g):

GL=24.6[GL=((40.1/2×71)+(14.6/2×32)+(6.0/2×100)+(15/2×68)/100]

A corresponding infant cereal product according to the present inventionmay be prepared according to the following recipe by using methods knownto the person skilled in the art: wheat flour 43% (38.3 g CHO), addedlactose 15%, skim milk 26% (14.6 g CHO), oil 13%, sucrose 2%, vitaminand minerals 1%. The GI of this example is 63 and GL of 20.

Calculation of Glycemic load (serving size of 50 g):

GL20=[GL=((38.3/2×71)+(14.6/2×32)+(15/2×46)+(2/2×68))/100]

Example 3

Example of Infant Cereal Prepared with Milk (% Weight).

A traditional infant cereal product to be reconstituted in milk isprepared according to the following recipe: Rice flour 75% (71 g CHO),glucose 7%, sucrose 15%, banana 2% (1.4 g CHO), vitamin and minerals 1%.

Calculation of Glycemic load (25 g serving size):

21−[GL=((71/4×85)+(7/4×100)+(15/4×68)+(1.4/4×61))/100]

A corresponding infant cereal product according to the present inventionmay be prepared according to the following recipe by using methods knownto the person skilled in the art: Rice flour 66% (62.5 g CHO), sucrose2%, galactose 20%, banana 4% (1.4 g CHO), fat 5%, fiber 2.0%, vitaminand minerals 1%.

Calculation of Glycemic load (serving size of 25 g):

16−[GL=((62.5/4×71)+(2/4×68)+(20/4×20)+(2.8/4×60)/100]

Example 4

Infant Cereal Product to be Prepared with Water (% Weight)

An infant cereal product to be reconstituted in water is preparedaccording to the following recipe: 23% refined wheat flour with 4% fiber(20 g available CHO with GI 71), 20% whole wheat flour with 8.6% fiber(14 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 gavailable CHO with GI 26), 15% Skim milk (8.4 g CHO, GI 32), 12% fat (noGI), 11% sucrose (GI 68), 4% prebiotic (no GI), vitamin and minerals 1%(no GI). (Serving size=50 g powder+150 ml water). Total sugar content:20% w/w

Calculation of Glycemic load (serving size of 50 g):

GL=18[GL=((20/2×71)+(14/2×71)+(8.2/2×26)+(8.4/2×32)+(11/2×68))/100]

Example 5

Infant Cereal Product to be Prepared with Water (% Weight)

An infant cereal product to be reconstituted in water is preparedaccording to the following recipe: 24% refined wheat flour with 4% fiber(21 g available CHO with GI 71), 15% whole wheat flour with 8.6% fiber(10.5 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 gavailable CHO with GI 26), 15% Skim milk (8.4 g CHO, GI 32), 15% fat (noGI), 4% prebiotic (no GI), 4% lactose (GI 46), 8% dried apple with 15%fiber (available CHO of 5.8 with GI 29), vitamin and minerals 1% (no GI)(Serving size=50 g powder+150 ml water). Total sugar content: 19% w/w

Calculation of Glycemic load (serving size of 50 g) provides: GL=15.4

[GL=((21/2×71)+(10.5/2×71)+(8.2/2×26)+(8.4/2×32)+(4/2×46)+(5.8/2×29))/100]

Reference Example 6

Infant Cereal Product to be Prepared with Water (% Weight)

A traditional infant cereal product to be reconstituted in water isprepared according to the following recipe: 52% refined wheat flour with4% fiber (43% available CHO with GI 70), 26% skim milk (14.6 g availableCHO, GI 36), 6% fat (no GI), 15% sucrose (GI 68), vitamin and minerals1% (no GI). (Serving size=50 g powder+150 ml water). Total sugarcontent: 30% w/w.

Calculation of Glycemic load provides: GL=22.7

GL=((43/2×71)+(14.6/2×32)+(15/2×68))/100

Example 7

Infant Cereal Product to be Prepared with Water (% Weight)

An infant cereal product to be reconstituted in water is preparedaccording to the following recipe: 27% refined wheat flour with 4% fiber(24 g available CHO with GI 71), 20% whole wheat flour with 8.6% fiber(14 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 gavailable CHO with GI 26), 15% Skim milk (8.4 g CHO, GI 32), 12% fat (noGI), 11% sucrose (GI 68), vitamin and minerals 1% (no GI). (Servingsize=50 g powder+150 ml water). Total sugar content: 20% w/w.

Calculation of Glycemic load (50 g serving size) provides:

GL=19.6[GL=((24/2×71)+(14/2×71)+(8.2/2×26)+(8.4/2×32)+(11/2×68))/100]

Example 8

Infant Cereal Product to be Prepared with Water (% Weight)

An infant cereal product to be reconstituted in water is preparedaccording to the following recipe: 28% refined wheat flour with 4% fiber(25 g available CHO with GI 71), 15% whole wheat flour with 8.6% fiber(10.5 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 gavailable CHO with GI 26), 15% Skim milk (8.4 g CHO, GI 32), 15% fat (noGI), 4% lactose (GI 46), 8% dried apple with 15% fiber (available CHO of5.8, GI 29), vitamin and minerals 1% (no GI) (Serving size=50 gpowder+150 ml water). Total sugar content: 19% w/w.

Calculation of Glycemic load provides: GL=16.8

[GL=((25/2×71)+(10.5/2×71)+(8.2/2×26)+(8.4/2×32)+(4/2×46)+(5.8/2×29))/100]

Although due to species differences SGL and GL differ in their absolutevalues, it is to be noted that the decrease in GL results in a 18.5% and33% reduction when comparing Reference Example 6 to, respectively,Example 4 and 5. This thus shows reduction in GL at least comparable towhat observed in rats with SGL when moving from traditional products toproducts according to the invention.

Example 9

Two complete infant cereals compositions according to the presentinvention (Prototype1 and Prototype 2) were compared in a clinical trialto a Reference existing complete infant cereal product.

The study design was a randomized, single center, double blind,crossover, with three test meals (reference existing infant cereal and 2infant cereal prototypes). Table 2 below shows the composition of infantcereal products.

TABLE 2 Main macronutrient composition of tested infant cereals (g/100 gpower) Reference Prototype 1 Prototype 2 Wheat refined flour (starch)40.5 16 15.5 Wheat whole grain starch 19.9 14.7 Glucose & maltose 20.58.0 8.3 sucrose 11.0 isomaltulose 5.0 Red lentil 14.0 14.0 Skim milk (ofwhich lactose) 27.0 (15.1) 14.8 (8.2) 14.4 (8.0) Added fibre 4.0 4.0Added Fat 9.0 12.0 15.3 Dried Fruit* 8.0 Added fructose 2.7 GL (50 gserving) 26 20 17 *2.1 g sucrose & 3.6 g fructose

Total sugar content (including milk lactose and fruit sugars) of testedmeals are; 38% in Reference diet, 27.3% in prototype 1 and 27% inprototype 2.

20 healthy men of 21-45 years old with BMI of 22.3±2.03 Kg/m2, consumedall 3 study infant cereals, after an overnight fasting, in a randomorder with at least 3 days interval between tests. The study wasperformed as per international standard ISO 26642, 2010.10.01 forglycemic index. The study meals were prepared with 75 g infant cerealpowder diluted with 225 ml of pre-boiled lukewarm water (40° C.) andconsumed within 10 minutes together with 250 ml water. Finger pickedcapillary blood samples were taken at fasting (−10 & 0 minutes beforetest meals) and following 15, 30, 45, 60, 90, 120, 150 and 180 minutesafter start of test meals intake.

Capillary blood glucose was analyzed by Cobas, using Roche GLUC2(04657527, Switzerland). Serum insulin was analyzed by AlphaLISA® HumanInsulin Immunoassay Kit, PerkinElmer Inc.

The postprandial 2 hours incremental area under curve (IAUC) of glucoseand insulin were calculated using the trapezoidal rule. Results ofpostprandial increase in glucose and insulin responses are presentedFIGS. 6-7 and 2-hr IAUC relative to Reference in FIGS. 8-9.

The results of the clinical trial clearly demonstrate the benefit ofreformulated infant cereal prototypes (having low of GL 20 and 17respectively) in lowering both postprandial glucose and insulinresponses relative to the Reference product (having high GL of 26).

Relative to the Reference product, the 2-hr glucose and insulin IAUCwere 15% and 22% lower in response to the Prototype 1 and 25% and 35%lower in response to the Prototype 2, respectively (p<0.05 in allcases).

1: A nutritional composition comprising: cereal flour in amount from 20 to 90% w/w; sugar in amount from 0 to 30% w/w; added sugar with low glycemic index in amount from 1 to 30% w/w; total amount of dietary fiber in amount from 1 to 25% w/w; added fiber in amount from 1 to 20% w/w; legume in amount from 1 to 40%; and fruit in an amount from 1 to 25% w/w of the nutritional composition. 2: The nutritional composition of claim 1, comprising fat in an amount from 8 to 20% w/w of the nutritional composition. 3: The nutritional composition of claim 1, comprising: cereal flour in amount from 33 to 50% w/w; sugar in amount from 5 to 25% w/w; added sugar with low glycemic index in an amount from 5 to 15% w/w; fat in an amount from 10 to 17% w/w; total amount of dietary fiber in amount from 6 to 10% w/w; added fiber in amount from 1.5 to 7% w/w; milk-based ingredient in an amount from 5 to 25% w/w; legume in amount from 5 to 40% w/w; and fruit in an amount from 1 to 18% w/w of the nutritional composition. 4: The nutritional composition of claim 1, wherein the added sugar with low glycemic index is selected from the group consisting of sucrose, lactose, isomaltulose, galactose, fructose, and mixtures thereof. 5: The nutritional composition of claim 1, wherein the added sugar with low glycemic index is 1 to 20% w/w of the nutritional composition. 6: The nutritional composition of claim 1, wherein the added fiber is 1 to 8% w/w of the nutritional composition. 7: The nutritional composition of claim 1, comprising a milk-based ingredient in an amount from 1 to 25% w/w of the nutritional composition. 8: The nutritional composition of claim 1, wherein the legume is 8 to 30% w/w of the nutritional composition. 9: The nutritional composition of claim 1, wherein the legume is 10 to 25% w/w of the nutritional composition. 10: The nutritional composition of claim 1, wherein the fruit is 1 to 15% w/w of the nutritional composition. 11: The nutritional composition of claim 1, wherein the nutritional composition has a glycemic load equal to or lower than
 20. 12: The nutritional composition of claim 1, wherein the cereal flour is 50 to 90% w/w of the nutritional composition. 13: The nutritional composition of claim 12, wherein the cereal flour comprises refined flour that is 30 to 50% w/w of the nutritional composition and whole grain flour that is 20 to 40% of the nutritional composition. 14: The nutritional composition of claim 1, comprising: cereal flour in amount from 50 to 90% w/w, the cereal flour comprising refined flour that is 30 to 50% w/w of the nutritional composition and whole grain flour that is 20 to 40% of the nutritional composition; total sugar in amount from 5 to 18% w/w; added sugar with low glycemic index in amount from 5 to 15% w/w; fat in an amount from 0 to 10% w/w; total amount of dietary fiber in amount from 2 to 22% w/w; added fiber in amount from 0 to 20% w/w; legume in amount from 5 to 40% w/w; fruit in an amount from 0 to 25% w/w. 15: The nutritional composition of claim 14, wherein the fat is 0 to 5% w/w, the added fiber is 5 to 18% w/w, the legume is 10 to 25% w/w, and the fruit is 1 to 18% w/w of the nutritional composition. 